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AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS

FDA premarket approval P880086/S237 · decided 2014-02-26

Approval details

PMA number
P880086
Supplement
S237
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Generic name
Pulse generator, permanent, implantable
Applicant
ABBOTT MEDICAL
Date received
2013-11-21
Decision date
2014-02-26
Days to decision
97 days
Decision code
APPR
Product code
NVZ
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.

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510(k) clearances by this applicant

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EnSite™ X EP System (K262006)Abbott Medical2026-07-15
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OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459)ABBOTT MEDICAL2026-04-24
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Disposable Radiofrequency Cannula (K253907)ABBOTT MEDICAL2026-04-16
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499)ABBOTT MEDICAL2026-03-13
Armada™ 14 NC PTA Catheter (K252512)ABBOTT MEDICAL2026-02-13
Assert-IQ (DM5100) (K253516)ABBOTT MEDICAL2025-12-18